(29 days)
The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:
- degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and
- failed previous fusion.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Cervical Plate system consists of multiple sized plates and screws. All components are fabricated from anodized titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the cervical spine.
The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.
The provided text describes a 510(k) submission for a medical device called "Cervical Plate." This submission details the device's design, intended use, and its substantial equivalence to a previously marketed device. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or in-vitro diagnostic study would.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device, which is a different kind of regulatory pathway. The "Summary Nonclinical Tests" section mentions "Testing was performed according to ASTM F1717," which refers to a standard for mechanical testing of spinal implant constructs. This typically involves biomechanical or material testing rather than assessing performance against clinical acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain this information. The documents are focused on regulatory approval via substantial equivalence based on design similarity and mechanical testing to an ASTM standard, not a clinical performance study with acceptance criteria.
To elaborate on why I cannot provide the requested information:
- Acceptance Criteria Table & Reported Device Performance: This type of table would typically present metrics like sensitivity, specificity, accuracy, or other clinically relevant measures and compare them against predetermined thresholds. This information is absent.
- Sample Size for Test Set & Data Provenance: This would refer to patient data used in a clinical study. The document does not describe such a study.
- Number of Experts & Qualifications for Ground Truth: This is relevant for studies involving human interpretation or diagnosis. Not applicable here.
- Adjudication Method: Also relevant for studies with human interpretation. Not applicable here.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is for evaluating AI-assisted performance compared to human readers. Not applicable as this is a physical medical device, not an AI diagnostic tool.
- Standalone Performance Study: This would describe the performance of an algorithm without human intervention. Not applicable.
- Type of Ground Truth: This would be clinical outcomes, pathology, expert consensus, etc. Not applicable to the information provided.
- Sample Size for Training Set: This is for machine learning models. Not applicable.
- How Ground Truth for Training Set was Established: Again, for machine learning. Not applicable.
The provided text focuses on the device's physical and mechanical characteristics, its intended use, and its similarity to an existing device, along with adherence to a mechanical testing standard (ASTM F1717), which is a common approach for spinal implants to demonstrate safety and efficacy through mechanical performance rather than clinical performance against specific disease-related acceptance criteria.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.